PS-341 in Treating Patients With Metastatic Kidney Cancer
A Phase II Trial of PS-341 in Patients With Renal Cell Cancer
Sponsor: National Cancer Institute (NCI)
Listed as NCT00025376, this PHASE2 trial focuses on Kidney Cancer and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 7 times since 2001, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)OBJECTIVES:
* Determine the objective response rate in patients with metastatic renal cell cancer treated with bortezomib.
* Determine the time to tumor progression and 1-year survival of patients treated with this drug.
* Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive bortezomib IV over 3-5 seconds twice weekly on weeks 1 and 2. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo core biopsy.
* Arm II: Patients undergo core biopsy. Patients then receive bortezomib IV as in arm I.
Patients undergo radiologic re-evaluation of measurable lesions. Patients with stable disease or a partial or complete response continue to receive bortezomib in the absence of disease progression or unacceptable toxicity.
Patients are followed for 2 years.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 9-14 months.
OBJECTIVES:
* Determine the objective response rate in patients with metastatic renal cell cancer treated with bortezomib. * Determine the time to tumor progression and 1-year survival of patients treated with this drug. * Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive bortezomib IV over 3-5 seconds twice weekly on weeks 1 and 2. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo core biopsy. * Arm II: Patients undergo core biopsy. Patients then receive bortezomib IV as in arm I.
Patients undergo radiologic re-evaluation of measurable lesions. Patients with stable disease or a partial or complete response continue to receive bortezomib in the absence of disease progression or unacceptable toxicity.
Patients are followed for 2 years.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 9-14 months.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 2 earlier versions
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE2
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Oct 2001
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Cancer Institute (NCI)
- University of Chicago
For direct contact, visit the study record on ClinicalTrials.gov .